Ignite Creation Date:
2025-12-24 @ 9:21 PM
Ignite Modification Date:
2026-03-12 @ 12:54 AM
Study NCT ID:
NCT01999504
Status:
COMPLETED
Last Update Posted:
2014-10-17
First Post:
2013-10-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gut Hormone Response After Paleolithic-type Meals
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-16', 'studyFirstSubmitDate': '2013-10-29', 'studyFirstSubmitQcDate': '2013-11-25', 'lastUpdatePostDateStruct': {'date': '2014-10-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Insulin/glucose ratio', 'timeFrame': '30 minutes', 'description': 'Ratio between insulin and glucose in blood as measured at 30 minutes after start of test product intake'}, {'measure': 'Ad libitum meal', 'timeFrame': '4 hours', 'description': 'Weight of an ad libitum pasta with tomato sauce meal consumed at 4 hours after test product intake'}, {'measure': 'Time to return to baseline of satiety score for fullness, hunger and desire to eat', 'timeFrame': 'up to 4 hours', 'description': 'Time to return to baseline for the scores on a Visual Analogue Scales for fullness, hunger and desire to eat'}, {'measure': 'Peptide hormones', 'timeFrame': '0-3 hours', 'description': 'Area under the Concentration versus time curve for total amylin, ghrelin, pancreatic polypeptide, C-peptide, leptin, interleukin-6, monocyte chemotactic protein-1 and tumour necrosis factor-alpha in blood plasma'}], 'primaryOutcomes': [{'measure': 'Glucagon-like peptide-1', 'timeFrame': '0-3 hours', 'description': 'Area under the Concentration versus time curve for Glucagon-like peptide-1 in blood plasma'}], 'secondaryOutcomes': [{'measure': 'Glucose-dependent Insulinotropic Peptide', 'timeFrame': '0-3 hours', 'description': 'Area under the Concentration versus time curve of Glucose-dependent Insulinotropic Peptide in blood plasma'}, {'measure': 'Fullness', 'timeFrame': '0-4 hours', 'description': 'Area under the curve for fullness scores (as rated by the subjects on a Visual Analog Scale) versus time'}, {'measure': 'Glucose', 'timeFrame': '0-3 hours', 'description': 'Area under the Concentration versus time curve of Glucose in blood'}, {'measure': 'Insulin', 'timeFrame': '0-3 hours', 'description': 'Area under the Concentration versus time curve of insulin in blood plasma'}, {'measure': 'Glucagon', 'timeFrame': '0-3 hours', 'description': 'Area under the Concentration versus time curve of Glucagon in blood plasma'}, {'measure': 'Peptide YY', 'timeFrame': '0-3 hours', 'description': 'Area under the Concentration versus time curve of Peptide YY in blood plasma'}, {'measure': 'Hunger', 'timeFrame': '0-4 hours', 'description': 'Area under the curve for hunger scores (as rated by the subjects on a Visual Analog Scale) versus time'}, {'measure': 'Desire to eat', 'timeFrame': '0-4 hours', 'description': 'Area under the curve for desire to eat scores (as rated by the subjects on a Visual Analog Scale) versus time'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Glucagon-like peptide-1', 'Glucose-dependent Insulinotropic Peptide', 'Peptide YY', 'Glucagon', 'Satiety', 'Meal', 'palaeolithic'], 'conditions': ['Insulin Resistance', 'Satiety']}, 'descriptionModule': {'briefSummary': 'The effects of two palaeolithic-type meals will be assessed with respect to a panel of gut hormones, satiety, blood glucose and insulin levels as compared to a meal constructed along the lines of the world Health Organisation dietary recommendations', 'detailedDescription': 'In the current study the effects of two palaeolithic-type meals will be assessed with respect to a panel of gut hormones (including incretins), satiety, blood glucose and insulin levels.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body Mass Index (BMI) 18-27 inclusive\n* Apparently healthy: no medical conditions which might affect study measurements as judged by Leatherhead physician based on a health questionnaire)\n* Having general practitioner\n* Reported dietary habits: no medically prescribed diet, no slimming diet, used to eat 3 meals a day, no vegetarian\n* Reported intense sporting activities less than 10h/w\n* Reported alcohol consumption less than 21units/w\n* non-smoking\n* A fasting capillary blood glucose value within the local normal reference value: 4-6.5 mmol/L measured by finger prick\n\nExclusion Criteria:\n\n* Use of medication which interferes with the study measurements (as judged by the study physician)\n* Being an employee of Unilever or Leatherhead Food Research\n* Scoff questionaire score ≥ 2\n* Eating habit questionnaire ≥ 14\n* Smoking\n* Dislike, allergy or intolerance t the test meals or the ad libitum meal\n* Reported participation in another nutritional or biomedical trial 3 months before pre-study examination or during the study\n* Reported participation in night shift work two weeks prior to the pre-study investigation during the study. Night work is defined as working between midnight and 06.00 AM'}, 'identificationModule': {'nctId': 'NCT01999504', 'acronym': 'FooA2', 'briefTitle': 'Gut Hormone Response After Paleolithic-type Meals', 'organization': {'class': 'INDUSTRY', 'fullName': 'Unilever R&D'}, 'officialTitle': 'Gut Hormone Response After Two Paleolithic-type Meals Compared to a Modern-type Meal Composed According to WHO Guidelines', 'orgStudyIdInfo': {'id': 'FDS-BNH-1268'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PAL-2', 'description': 'Based on WHO dietary guidelines for protein, fat and carbohydrate but made with ingredients that would have been available in palaeolithic times (e.g. no cereals, no dairy).', 'interventionNames': ['Other: PAL-2']}, {'type': 'EXPERIMENTAL', 'label': 'TFH-1', 'description': 'Based on WHO dietary guidelines for protein, fat and carbohydrate but made with ingredients that would have been available in palaeolithic times, (e.g. no cereals, no dairy).', 'interventionNames': ['Other: TFH-1']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Reference', 'description': 'Meal based on WHO dietary guidelines for protein, fat and carbohydrate.', 'interventionNames': ['Other: Reference']}], 'interventions': [{'name': 'PAL-2', 'type': 'OTHER', 'description': 'meal', 'armGroupLabels': ['PAL-2']}, {'name': 'TFH-1', 'type': 'OTHER', 'description': 'Meal', 'armGroupLabels': ['TFH-1']}, {'name': 'Reference', 'type': 'OTHER', 'description': 'Meal', 'armGroupLabels': ['Reference']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'KT22 7RY', 'city': 'Leatherhead', 'state': 'Surrey', 'country': 'United Kingdom', 'facility': 'Leatherhead Food Research', 'geoPoint': {'lat': 51.29652, 'lon': -0.3338}}], 'overallOfficials': [{'name': 'Carmen Diaz-Toledo Trenado', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Leatherhead Food Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Unilever R&D', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Leatherhead Food Research', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}